Historically, the rules around the Generally Recognized as Safe (GRAS) provisions have sparked various initiatives for change. Now there is a new push with a recently introduced bill in the Senate calling for updates to the GRAS rule that would significantly increase the process and the regulatory oversight of GRAS substances. With the current process of GRAS self-determination being seen by some as “the fox guarding the henhouse,” the Ensuring Safe and Toxic-Free Foods Act of 2022 would significantly add to the process of GRAS determination to require the involvement of both regulators and non-biased experts.
Although there may be varying perceptions regarding the current voluntary GRAS notification procedure, the FDA points out the following:
“For a substance to be GRAS under the conditions of its intended use, two criteria must be met:
- the use of the substance must meet the same safety standard as a food additive: there must be a reasonable certainty of no harm under the conditions of its intended use; and
- the use of the substance must meet the general recognition standard: the intended use of the substance in food must be recognized as safe by qualified experts based on publicly available scientific information.”
Therefore, the burden of safety is just as high for GRAS materials as for those that must follow the food additive petition process. FDA would likely take action on any material declared to be GRAS if it were associated with harm to humans or animals.
However, the proposed Act would add to GRAS requirements: prohibiting manufacturers from designating substances as safe without supplying proper notice and information, requiring the public posting and review on the FDA website, prohibiting GRAS designation for carcinogenic substances and those that show evidence of reproductive or developmental toxicity, and not allowing those with conflicts of interest to serve as experts for the review/evaluation of the scientific data for GRAS designation. While this increased oversight could provide better outcomes from companies that currently take advantage of the current process without proper, thorough assessment and notification, without additional resources for FDA it could stifle the speed of innovation for those who have done things right, and further bottleneck the FDA which is already constrained. The two sides of the issue have made the issue a hotly contested debate between NGOs and the industry.
To provide further insights into the proposed Act, it would:
- … set new requirements for the marketing or use of a GRAS substance, with new requirements for information the manufacture must provide, provide for public accessibility, and prohibit manufacturers from marketing/manufacturing/selling food with the substance unless the Secretary has made a final determination of approval.
- …define substances that cannot be GRAS, including those that are known, or reasonably anticipated, to cause cancer in humans or show evidence of human reproductive or developmental toxicity. Additionally, any not marketed for use in foods in the US before issuance of the revised rule must go through the approval process.
- … provide for substance assessment through the establishment of an Office of Food Chemical Safety Reassessment in CFSAN, to conduct reassessments of the safety of food additives, food contact substances, GRAS substances, color additives, and prior-sanctioned substances.
- …require reassessment at least once every 3 years of at least 10 of the above substances or classes, with the issuance of final regulations on their safety and conditions of use; or the determination that it is unsafe.
- … provide for the initial reassessment of 10 substances/classes: Perfluoroalkyl substances and polyfluoroalkyl substances, Ortho-phthalates, The class of bisphenols, Titanium dioxide, Potassium bromate, Perchlorate, Butylated hydroxyanisole (BHA), Butylated hydroxytoluene (BHT), Brominated vegetable oil (BVO), Propyl paraben.
- … require the posting of Federal Register notices prior to selecting further substances/classes for assessment; and post a request for information, recommendations, and information on any prior-sanctioned, food contact, or GRAS food uses prior to commencing the assessment
- … establish a standing Food Chemical Committee within the Science Board to the FDA to meet regularly and advise the Secretary on the standards for reassessments.
- .. establish a timeframe requiring that FDA publish a proposed rule within one year, final rule within 180 days of comment period close, and draft guidance within 180 days of enactment
As the issue continues to be contested between industry and NGOs, the industry may win simply by default, at least for the time being. That is, given all the legislative priorities and bills on the Congressional agenda, the Act has little chance of getting much further in the process and even less potential for final passage.
But don’t expect that to put an end to the GRAS debate. It has been going on for years. In 2016, FDA published the Substances Generally Recognized as Safe (GRAS) Final Rule which, even at the time, TAG saw as changing little. While it addressed the types of scientific evidence and the role of publications by which manufacturers could demonstrate GRAS safety and FDA “strongly encourage(d) companies to inform the agency of GRAS conclusions through the notification procedure,” the determination was still made by the manufacturer and notification continued to be voluntary. The rule’s leniency was further validated by a federal court opinion that confirmed the GRAS regulatory framework as lawful, affirmed the exemption of self-determined GRAS substances from premarket review by FDA, and held that the NGO complaints lacked merit under the law.
It will be interesting to see how this all progresses, but whichever way it goes, we would not expect any major changes any time soon.